A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction
1 other identifier
interventional
48
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 negative adenocarcinoma at gastroesophageal junction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2017
CompletedFirst Posted
Study publicly available on registry
November 22, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedFebruary 19, 2020
February 1, 2020
2 years
November 17, 2017
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The pathological complete response rate(pCR)
The lesion disappeared completely by pathology
within 3 weeks after surgery
Secondary Outcomes (5)
Objective response rate (ORR)
within 3 weeks after surgery
R0-resection rate
within 3 weeks after surgery
Disease-free survival(DFS)
3 year
Overall survival (OS)
3years
Adverse events
3 year
Study Arms (2)
apatinib XELOX and radiotherapy
EXPERIMENTALapatinib：250mg qd po XELOX：Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w）
XELOX and radiotherapy
ACTIVE COMPARATORXELOX：Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w）
Interventions
45Gy/25f （1.8Gy/f/d，5 f/w）
Eligibility Criteria
You may qualify if:
- Age:18 to 70 years old (man or female);
- Confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy and CT, The her-2 negative was detected by immunohistochemistry;
- Patients with Stage for Ⅲ by CT/MRI (According to the eighth edition of AJCC );
- Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Major organ function has to meet the following certeria:
- HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; ALT and AST≤2.5×ULN, but\<≤5×ULN if the transferanse elevation is due to liver metastases； TBIL\<1.5×ULN； Serum creatinine ≤1.5×ULN;
- Life expectancy greater than or equal to 6 months;
- Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
- Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
You may not qualify if:
- Allergic to apatinib, capecitabine and oxaliplatin;
- The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive;
- Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg), Uncontrolled coronary heart disease and arrhythmia ,classⅢ-Ⅳcardiac insufficiency;
- A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
- Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;
- Coagulant function abnormality (INR \> 1.5 ULN, APTT \> 1.5 ULN), with bleeding tendency;
- Pregnant or lactating women;
- Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Less than 4 weeks from the last clinical trial;
- The researchers think inappropriate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Related Publications (1)
Guo H, Li Y, Lin C, Cheng Y, Zhang Z, Wang D, Zhao X, Liu Y, Jing S, Yang P, Tian Y, Liu Y, Wang J, Zhao Q. Efficacy and safety of neoadjuvant chemoradiotherapy plus apatinib for patients with locally advanced, HER2-negative, Siewert's type II-III adenocarcinoma of esophagogastric junction: a single-arm, open-label, phase II trial. Am J Transl Res. 2021 Aug 15;13(8):9015-9023. eCollection 2021.
PMID: 34540013DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qun Zhao
Hebei Medical University Fourth Hospital
- PRINCIPAL INVESTIGATOR
Jun Wang
Hebei Medical University Fourth Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 17, 2017
First Posted
November 22, 2017
Study Start
November 30, 2017
Primary Completion
November 30, 2019
Study Completion
November 30, 2020
Last Updated
February 19, 2020
Record last verified: 2020-02